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A Coordinating Center is responsible for overall data management, monitoring and communication among all sites, and general oversight of conduct of the project. A Coordinating Center may be designated either by a sponsor or by mutual agreement of the participating sites.
The JHM IRBs recognize that there are two possible ways for a PI to submit for review protocols describing the Coordinating Center functions when a Hopkins investigator will serve as the PI of a coordinating center:
- The Hopkins PI will submit a specific Coordinating Center protocol that outlines the responsibilities of the Center and does not include local site protocol information. In this case, the Coordinating Center protocol must be submitted to the IRB for review and approval prior to initiating the Center functions. The Hopkins PI may or may not be the PI of a local site protocol.
- The Hopkins’ PI will both enroll subjects for the multi-center study and serve as the Coordinating Center PI. In such cases, there will be a local site protocol that describes the study into which subjects will be enrolled, but a specific Coordinating Center protocol may or may not be available as a separate protocol submission. The Coordinating Center functions may be described in the local site protocol. The IRB will review the application materials submitted to determine if the Coordinating Center functions are described.
In either case (1 or 2), the IRB should confirm that the application materials indicate how the following issues are addressed:
- Central review of each sites local IRB approval documents and consent forms.
- Confirmation that each participating site has on file an FWA with OHRP
- Method for assuring all sites have the most current version of the protocol.
- System to confirm that amendments to the protocol will be communicated to all sites.
- Plan for collection and management of data from all sites.
- Process for reporting and evaluating protocol events and deviations from participating sites.
Multi-center and multi-site refer to a project that will be conducted at Johns Hopkins and non-Johns Hopkins controlled locations. The JHM IRB defines a multi-center study as a clinical trial that is written to include conduct of a model protocol carried out at more than one medical institution. As part of the application, the investigator shall disclose to the JHM IRB who will serve as the coordinating center for the project.
A multi-site study is defined as a study where the JHM investigator is conducting research at a site(s) not under the control of the Organization. Examples include public elementary schools, nursing homes, health care facilities, private practices, etc. The following information must be provided on the application form for multi-site studies:
- Name of site
- Name of contact at the site
- Contact information (phone or email)
- Has the site provided permission to conduct the research at that site?
- Does site have an IRB?
- Has the site’s IRB approved the research?
- Does the site plan to rely on the JHU SOM IRBs?
IRB staff will check this information on the application.
In order to grant final approval, IRB staff will ensure that:
- All sites have provided permission to conduct the research at the site
- If the site has an IRB, the IRB has either approved the research, or the site has deferred approval to the JHM IRBs.
Final approval will be withheld until the JHM IRB has all required documentation on file.
If any problems arise with external sites, IRB staff will communicate with the contact person named on the application.